MAUDE Adverse Event Report: Covidien LigaSure XP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LXMJ23L
Medical Device Problem Codes	Difficult to Open or Close (2921); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: LigaSure XP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): Covidien; 6044 longbow court; boulder CO 80301 -329
• Manufacturer (Section G): Covidien; 6044 longbow court; boulder CO 80301 -329
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50124889
• Report Number: 1717344-2026-01047
• Device Sequence Number: 16101118
• Product Code: GEI
• UDI-Device Identifier: 10884521830912
• UDI-Public: (01)10884521830912(17)310115(10)60150153X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K223158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LXMJ23L
• Device Catalogue Number: LXMJ23L
• Device Lot Number: 60150153X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown